NCT02560103

Brief Summary

Observational study to investigate circadian rhythm patterns

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

2.1 years

First QC Date

September 21, 2015

Last Update Submit

June 22, 2018

Conditions

Jet Lag Disorder

Outcome Measures

Primary Outcomes (2)

  • Effects of transmeridian travel on nighttime sleep after transmeridian travel measured by Polysomnography (PSG)

    4 days

  • Karolinska Sleepiness Scale (KSS) in subjects who experienced rapid transmeridian travel.

    4 days

Study Arms (1)

Single group

No treatment

Other: Transmeridian travel across multiple time zones

Interventions

Transmeridian travel across multiple time zonesOTHER
Single group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

  • Ability and acceptance to provide written consent
  • Men or women between 18-75 years
  • Body Mass Index of ≥ 18 and ≤ 30 kg/m2

You may not qualify if:

  • History (within the 12 months prior to screening) of psychiatric disorders
  • Major surgery, trauma, illness or immobile for 3 or more days within the past month
  • Pregnancy or recent pregnancy (within 6 weeks)
  • A positive test for drugs of abuse at the screening visit
  • Any other sound medical reason as determined by the clinical investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Santa Monica Clinical Trials

Santa Monica, California, 90404, United States

Location

The Center for Sleep & Wake Disorders

Chevy Chase, Maryland, 20815, United States

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 25, 2015

Study Start

September 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

June 26, 2018

Record last verified: 2018-06

Locations

US(2)